510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K874596Substantially Equivalent

Perforated Soaking Tube

Specialty Medical Products Co., Bountiful UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K874596 is the FDA 510(k) clearance record for PERFORATED SOAKING TUBE, a class I device, cleared for Specialty Medical Products Co. on under FDA product code GBQ (Catheter, Continuous Irrigation). FDA records list 4 510(k) clearances for Specialty Medical Products Co., from to . As of , FDA records show no recalls naming K874596.

Clearance record

Decision date
Received
(23 days to decision)
Product code
GBQ Catheter, Continuous Irrigation
Regulation
21 CFR 878.4200
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Specialty Medical Products Co. 3063 S. Davis Blvd., Bountiful UT
Third party review
No

Clearances, product code GBQ

Trailing 12 months

FDA records hold no clearances under product code GBQ in the trailing twelve months.

FDA records show no clearances under product code GBQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GBQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260